ISC 280 Validation Fundamentals

This course covers the fundamental concepts of components of a validation program in a cGMP environment. Emphasis is placed on FDA requirements concerning validation, types of validation, documentation, procedures, and the QA role. Upon completion, students should be able to discuss the purpose of validation, identify the steps in the validation process, and effectively utilize sample documentation.

Course is typically offered in Spring
Student Learning Outcomes (SLOs)
Upon completion of the course, students should be able to do the following:

1. Explain the purpose and importance of validation within the biomanufacturing process.
2. Describe FDA regulations and guidelines related to validation.
3. Describe different types of validation in a cGMP environment.
4. Explain the key steps involved in a validation process.
5. Create sample validation documentation to maintain cGMP compliance.
6. Define the role of Quality Assurance (QA) to adhere to regulatory and company standards.